The Effects of Epidermal Growth Factor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis. A phase II open-label safety and efficacy study.

VU University Medical Center0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•A subject is eligible for inclusion in this study only if all of the following criteria apply:
•1. Written informed consent;
•2. Systemic sclerosis;
•3. PAH with a mean PAP of above 25 mmHg measured during rest;
•4. PVR above 300 dynes;
•5. TLC > 70 %;
•6. NYHA class III and/or 6 Minute Walk Test < 80% predicted;
•7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment;
•8. Stability on medication during the previous 3 months (defined as stable or decrease of 6 MWT after 3 months of treatment).

•A subject will be excluded from this study in case of the following criteria:
•1. Left ventricular dysfunction;
•2. Valvular heart disease;
•3. Pericardial constriction;
•4. Wedge pressure >/= 15 mmHg;
•5. Chronic thromboembolic pulmonary hypertension;
•6. Uncontrolled sleep apnea;
•7. History of malignancies;
•8. Overt right heart failure;
•9. History or presence of skin ulcerations;
•10. Women of child-bearing potential (WOCB) who are unwilling or unable to use contraceptives;
•11. Sexually active fertile man not using effective birth control if their partners are WOCB;
•12. Severe abnormality of the cornea;
•13. Inadequate hematologic function defined by an absolute neutrophil count < 1,500/mm3, platelet count < 80.000/mm3 and hemoblobin level of < 9 g/dL;
•14. Inadequate hepatic function defined by a total bilirubin level 1.5 times the upper limit of normal (ULN) and ASAT levels 2.5 times ULN;
•15. Inadequate renal function defined by a serum creatinine level > 1,5 times ULN (alternative: Cockroft <50 ml/min);
•16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole (see section 6.4.5).

发起方

VU University Medical Center